BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4152731 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18552
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODES NO LONGER APPLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A POST-MARKET CLINICAL STUDY. THE PATIENT HAD REPORTED AN ABNORMAL HEADACHE ON (B)(6) 2014. AT THAT TIME, THE MEDICATION FIORICET WAS ADMINISTERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON 2014-(B)(6), THE PATIENT REPORTED A HEADACHE. THE HEALTHCARE PROVIDER (HCP) PERFORMED AN EPIDURAL BLOOD PATCH ON THE SAME DAY. NO FURTHER ACTIONS WERE TAKEN. IT WAS DETERMINED THAT A POST-DURAL HEADACHE AND CEREBROSPINAL FLUID (CSF) LEAK OCCURRED. THE EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON 2014-(B)(6). THE EVENT WAS INDICATED TO BE RELATED TO A PROCEDURE. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630974 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention